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S09 : FDA and PMDA Update: Oncology Drug Development and Regulation
Session Chair(s)
Shinichi Okudaira
Division Director Division of International Cooperation
Pharmaceuticals and Medicals Devices Agency (PMDA), Japan
R. Angelo De Claro, MD
Associate Director for Global Clinical Sciences, Oncology Center of Excellence
FDA, United States
Speaker(s)
R. Angelo De Claro, MD
FDA, United States
Associate Director for Global Clinical Sciences, Oncology Center of Excellence
Regulatory Framework for Facilitating Development of Oncology Drugs in Japan
Masakazu Hirata, MD, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Clinical Reviewer, Division of RS Consultation, Kansai Branch
Richard Pazdur, MD
Food and Drug Administration (FDA), United States
Director, Oncology Center of Excellence, CDER
Hiroshi Yaginuma
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Director, Office of New Drug V
Yoko Aoi, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Deputy Review Director, Office of New Drug V
Dianne Spillman
U.S. Food and Drug Administration , United States
Associate Director, Global Regulatory Outreach, OCE
Kristina Larsson, MS
European Medicines Agency, Netherlands
Head of Orphan Medicines, Division for Human Medicines Evidence Generation
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